FDA Continues E-Cigarette Crackdown with Surprise Inspection at JUUL Labs

Published on October 3, 2018 by Sandy Liebhard

Inspectors from the U.S. Food & Drug Administration (FDA) made a surprise visit to San Francisco-based JUUL Labs last week, as part of the agency’s ongoing crackdown on e-cigarette sales and marketing that targets minors.

JUUL Labs sells trendy, USB-shaped vaporizers that deliver a quick dose of nicotine. The liquid “pods” used with JUUL vaporizers are available in flavors like mango and crème, a feature that has made them popular among children and teens.

It is illegal to market or sell tobacco products, including e-cigarettes, to anyone under the age of 18. Yet, e-cigarettes are the most commonly used tobacco products among middle- and high-school students, according to the 2017 National Youth Tobacco Survey.

Many Young JUUL Users Unaware Product Contains Nicotine

JUUL Labs controls about 73% of the e-cigarette market. What’s more, a Research Letter published Tuesday in JAMA reported that sales of the company’s products grew by a whopping 641% between 2016 and 2017.

“The popularity of JUUL among kids threatens our progress in reducing youth e-cigarette use,” said Dr. Robert Redfield, director of CDC, in a press release issued the same dy. “We are alarmed that these new high nicotine content e-cigarettes, marketed and sold in kid-friendly flavors, are so appealing to our nation’s young people.

In April, a survey of young JUUL users conducted by the nonprofit tobacco control group, Truth Initiative, found that 63% did not know that the e-cigarettes contained nicotine.

That same month, the FDA requested materials from JUUL Labs regarding its products’ appeal to children and teens.

FDA Announced E-Cigarette Crackdown in September

JUUL Labs was one of several manufacturers that received FDA warning letters last month, amid concerns that youth e-cigarette has reached epidemic proportions.

“I’ve been warning the e-cigarette industry for more than a year that they needed to do much more to stem the youth trends,” FDA Commissioner Scott Gottlieb, M.D., said in a statement announcing the agency’s crackdown.

“In my view, they treated these issues like a public relations challenge rather than seriously considering their legal obligations, the public health mandate, and the existential threat to these products.”

JUUL Labs and the other companies – including R.J. Reynolds Vapor Co.’s Vuse, Altria Group’s MarkTen, Imperial Brands’s blu, and Japan Tobacco’s Logic devices — were given 60 days to formulate a strategy for making their products less appealing to minors.

JUUL Labs CEO: “We Want to be Part of the Solution. . .”

Last week’s surprise inspection was part of the FDA’s “ongoing efforts to prevent youth use of tobacco products, particularly e-cigarettes.”

In a statement issued earlier this week, JUUL Labs disclosed that it had submitted 50,000 pages of internal documents in response to the FDA’s April request.

CEO Kevin Burns insisted that the company was committed to reducing youth e-cigarette use.

“We want to be part of the solution in preventing underage use, and we believe it will take industry and regulators working together to restrict youth access,” he said.